Breast Cancer, Cervical Cancer, Colorectal Cancer, Lung Cancer
Conditions
Keywords
Smoking cessation, Cancer screening, Appalachia, Group-randomized trial, Faith-placed
Brief summary
The study purpose is to evaluate the effectiveness of a set of culturally appropriate, faith-placed lay health advisor interventions aimed at facilitating smoking cessation and increasing cancer screening among Appalachian participants.
Detailed description
The developmental phase of this project incorporated community based participatory research (CBPR) principles to identify the needs and preferences of community members with regard to cancer prevention. In the intervention phase, this group-randomized trial administers and evaluates a set of culturally appropriate interventions aimed at facilitating smoking cessation and increasing cancer screening among participants in 6 distressed Appalachian counties. Faith institutions are recruited and randomized to treatment or wait-list control conditions, and participants are recruited and enrolled within those institutions. Participants select one or more targeted health behaviors from a menu including smoking cessation, colorectal cancer screening, cervical cancer screening, and breast cancer screening, and subsequently receive the intervention(s) aimed at their selected health behaviors.
Interventions
BEHAVIORALLay health advisor interactions
For smoking cessation: Cooper-Clayton group sessions plus motivational interviewing, both delivered by local lay health advisor. For all cancer screenings: lay health advisor home visits incorporating motivational interviewing and focused on decreasing participant-identified barriers to screening.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Nancy Schoenberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* For smoking cessation: age 18 or older; current cigarette smoker; able to provide informed consent * For cervical cancer screening: female; age 18 or older AND outside of screening guidelines; able to provide informed consent * For breast cancer screening: female; age 40 or older AND outside of screening guidelines; able to provide informed consent * For colorectal cancer screening: age 40 or older AND outside of screening guidelines; able to provide informed consent
Exclusion criteria
* For smoking cessation: None * For cervical cancer screening: History of cervical cancer; history of hysterectomy * For breast cancer screening: History of breast cancer * For colorectal cancer screening: History of colorectal cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants reporting the health behavior of interest (depending on which intervention component(s) were selected) | Assessed approximately 4 months after baseline | For smoking cessation: Self-reported smoking status. For cancer screenings: Self-reported receipt of cervical, breast, and/or colorectal cancer screening. This assessment occurs after the Early Treatment group has completed the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in stage of readiness to change the selected health behavior(s) from baseline | Assessed approximately 4 months after baseline | Measured using reliable and valid instruments which were pretested in focus groups comprised of members of the target population. Positive change (i.e., increasing stage of readiness) from baseline to post-test will be coded as 1, while negative or no change will be coded 0. This assessment occurs after the Early Treatment group has completed the intervention. |
| Number of visits completed | Approximately 4 months after baseline | This process measure will reflect the number of visits/classes attended by participants, as a means of assessing participation rate and feasibility. |
| Retention (i.e., number of participants who complete all planned assessment timepoints) | Approximately one year after baseline | Retention numbers will be assessed as a process measure outcome. Participants who complete all study assessment timepoints will be coded as 1, while participants who drop out will be coded 0. Number/percentage of participants who remained enrolled and complete all study procedures and assessments will be used as an indicator of feasibility in the community setting. |
Countries
United States
Outcome results
None listed